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SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKOR…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K230049

by Ttk Healthcare Limited

Identifiers

510(k) Number
K230049 FDA 510(k)
FDA Product Code
HIS FDA 510(k)
Models / Variants
SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine FDA 510(k)
SKORE Bulbous Condoms - SKORE WARM, SKORE COOL FDA 510(k)
SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5300 FDA 510(k)
Regulation Number
884.5300 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKOR… by Ttk Healthcare Limited — Class II — FDA_510K — listed in FDA 510(k) — 3…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ttk Healthcare Limited

Sources (1)

  • FDA 510(k) K230049 24 fields · synced Jun 18, 2026